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Clinical Trials/EUCTR2013-000488-95-AT
EUCTR2013-000488-95-ATActive, not recruitingPhase 1

Efficacy and tolerability of nicotinamide as add-on therapy compared to placebo in dialysis-dependent patients with hyperphosphatemia - NOPHOS Trial

MEDICE Arzneimittel Pütter GmbH & Co. KG0 sites700 target enrollmentStarted: August 29, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
700
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Males or females aged 18 years or older
  • •? Patients with CKD stage 5 and on a stable haemodialysis regimen, 3 times a week for at
  • •least 6 months prior to screening
  • •? Study visits must be conducted either on Sunday, Monday (morning, midday/afternoon,
  • •evening or overnight dialysis session) or on Tuesday (morning or midday/afternoon
  • •dialysis sessions)
  • •? Dialysis regimen should remain constant at least until study visit W12
  • •? Unmodified phosphate binding therapy with one or two phosphate binders for at least 1
  • •month prior to screening
  • •? Serum phosphate concentration at screening < 2.80 mmol/l (8.7 mg/dl) and > 1.45
  • •mmol/l (4.5 mg/dl)
  • •? If the patient is on vitamin D replacement and active vitamin D therapy, the dose must
  • •have remained stable for at least 1 month prior to screening
  • •? If the patient takes calcimimetics, the dose must have remained stable for at least 1
  • •month prior to screening
  • •? Patient is willing and able to regularly attend the examination and follow-up appointments
  • •? Written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 315
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 385

Exclusion Criteria

  • •? Chronic heart failure NYHA III or IV in adequate volume state.
  • •? Cardiac decompensation requiring hospital admission in the last 6 months
  • •? Myocardial infarction in the last 6 months
  • •? Uncontrolled hypertension although receiving 3 or more antihypertensive medications
  • •? Patient with planned parathyroidectomy in the next year
  • •? High urgency transplant candidate as defined at Eurotransplant at screening
  • •? Peptic ulcers in the last 6 months
  • •? Gastro-intestinal haemorrhage –except anal skin tags- in the last 6 months
  • •? Patients with dysphagia or swallowing difficulties in the last 6 months
  • •? Intestinal obstructions / ileus in the last 6 months
  • •? Patients with impaired intestinal absorption (e.g. impaired intestinal motility, pseudo-
  • •obstructions, megacolon, short bowel syndrome, Crohn's or coeliac disease)
  • •? Active gastroparesis, identifiable from nausea and vomiting
  • •? Rhabdomyolysis
  • •? Severely impaired vision (e.g. macular edema, severe nonproliferative retinopathy or
  • •proliferative retinopathy)
  • •? Severe liver disease (especially persistent Hepatitis B/C/D with viral load, cirrhosis or
  • •severe fibrosis according to IASL 4 (Numerous bridges or septa, liver cancer, liver transplantation planned or performed))
  • •? Hypersensitivity to nicotinamide or one of the other ingredients
  • •? Absolute or severe lactose intolerance
  • •? Simultaneous participation in another clinical trial within the last 2 months
  • •? Patients who are legally incapacitated or are institutionalized by court or official order
  • •? Patient with an inadequate command, or no command of written and spoken national
  • •? Failure to use highly-effective contraceptive methods in women of child-bearing age. The
  • •following contraceptive methods with a Pearl Index lower than 1% are regarded as
  • •highly-effective:
  • •? Tubal ligation (female sterilisation)
  • •? Intrauterine devices that release hormones (hormone spiral)
  • •? Vaginal hormonal contraception
  • •? Dermal hormonal contraception
  • •? Contraceptive plaster
  • •? Long-acting injectable contraceptives
  • •? Implants that release progesterone
  • •? Double barrier methods
  • •o This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
  • •? sexual abstinence or vasectomised partner can also considered as adequate as investigators discretion (taking patient’s medical history and lifestyle into account)
  • •? Alcohol, drug or pharmaceutical abuse within the last year prior to trial commencement
  • •? Known persistent (> 1 month before inclusion) non compliance (< 70%) with prescribed
  • •medication regimes.
  • •? Nursing mother

Investigators

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